Job Title

Overview - You will play a crucial role in supporting the regulatory activities across the developmental lifecycle of our biopharmaceutical products. This position requires a blend of managerial skills, regulatory understanding and technical expertise. Note - There are multiple positions Executive / Sr. Eecutive /Assistant Manager / Deputy ManagerKey Responsibilities:Drafting of the eCTD sections for regulated market such Europe, USA, Canada, Brazil etc. for biological products and/or synthetic peptidesPreparation/finalization of the briefing book for scientific advice, for EMA, UK HMRA etc.Preparation/ finalization of the briefing book for biological development meetings like BPD Type 2, Type 3 and Type 4Coordination for drafting and review of IMPD, IND for clinical trial applications to HAHandling the customer/regulatory queriesRegulatory inputs for developmental stages of the product life cyclePreparation of pre-submission meetings packages for USFDA, EMA, HC, TGACollation of the modules for BLA/NDA/EU MAA etc.Organizing all required things for sequence preparation and publishing activity for regulated market using eCTD softwareLead the regulatory discussion as regulatory manager in cross-functional project teams and workstreamsLead the coordination, planning, and submission of dossiersReview of source documentsExperience & Qualification-Qualification: Ph. D.; Master's degree in a Pharmacy, Life Sciences, or a related field (e.g., Biology, Biotechnology, Biochemistry, Pharmacy).Experience Range: 5 to 15 years in biotechnology industries with global regulatory affairs role focused on end to end product life cycle management (minimum 2 - 5 years in biosimilar Regulatory affairs)Technical Skill Requirement:Good understanding of Biopharmaceutical / Biosimilar Product development activities In depth understanding of global regulatory reqauirements for biosimilarsUnderstanding of product lifecycle for USFDA, EMA, CanadaSoftSkill Requirement:Strong organizational skills with attention to detailing. Good interpersonal skills to collaborate across functions and all levels.Problem solving: Ability to analyze data and situations, identify issues, and propose solutions to ensure regulatory compliancePersonal Attributes:Team Player: Ability to work effectively in a collaborative, cross-functional environment.Adaptability: Willingness to learn and adapt to evolving regulations and industry standards.Integrity: Commitment to upholding ethical standards and maintaining the highest level of quality in all activitiesStrong communication skillsGood capabilites to guide/mentor the Team memebers